Evaluation of the benefits and effects of hypericin Photodynamic therapy (PDT) in the clinical treatment of superficial bladder carcinoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001302-25-BE

Enrollment

Registered

2009-09-08

Start date

2009-11-05

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the study population consists of 10 patients with anatomopathologically proven muscle invasive TCC without metastasis. These patients require a cystoscopy. Before the planned cystoscopy, the bladders will be emptied and a 9µM PVP-hypericin solution will be instilled for 2 hours. Next, the bladder will be irradiated. 30 minutes to 1hour after irradiation, the bladder will be removed and investigated on residual tumor, tumor necrosis and affected normal urothelium. MedDRA version: 9.1 Level: LLT

Interventions

Product Name: PVP-Hypericin Product Code: SPH-3542 Pharmaceutical Form: Bladder irrigation INN or Proposed INN: not available CAS Number: 147850-99-5 Other descriptive name: Hypericin Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Bladder tumor which requires cystectomy * Anatomopathologically proven TCC * No distant metastasis * General condition of the patient is good enough for cystectomy * life expectancy is at least 1 year * TUR at least 6 weeks before cystectomy * Signed informed consent * instillation fluid needs to be retained in the bladder for 5 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Distant metastatsis * Life expectancy less than 1 year * TUR less than 6 weeks before planned cystectomy * Poor general condition whereby the patient can't undergo cystectomy * Evacuation of the instillatin fluid if it is retained less than 2 hours in the bladder

Design outcomes

Primary

Measure	Time frame
Main Objective: Hypericin PDT of human bladder TCC and CIS. * Assessment of the optimal light dose and safety of hypericin PDT in patients requiring cystectomy. ;Secondary Objective: * Optimize light dose for PDT;Primary end point(s): Since PDT will be performed before removal of the bladder, primary and secondary endpoints are not applicable	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026